The present invention relates generally to a portable storage case for housing a medical monitoring device and, more particularly, to a portable storage case and an associated method for housing a medical monitoring device and for facilitating communication therewith.
In addition to the periodic examination by a physician in the physician""s office, it is oftentimes desirable to monitor the medical condition of a patient on a more frequent basis including at times during which the patient is otherwise engaged in normal day-to-day activities. For example, diabetic patients must generally test their blood sugar several times a day. If the blood sugar readings are either abnormally high or abnormally low, the patient can then take appropriate remedial action in order to bring their blood sugar back within the normal range. For example, the patient may administer an insulin shot, drink a glass of orange juice, eat a candy bar or rest for a while in order to allow their blood sugar to return to normal. As another example, patients suffering from various types of heart conditions may need to monitor their blood pressure, pulse rate and the like on a fairly frequent basis throughout the day such that a patient can identify instances in which they should rest and/or relax in order to maintain their blood pressure, pulse and the like at normal levels.
Patients who are both knowledgeable of their medical condition and diligent in monitoring their medical condition can generally identify instances in which remedial action is desirable and then decide upon and institute the appropriate remedial action, such as by adjusting their medication, diet and/or their level of exertion, on an ongoing basis such that they remain in a relatively stable condition. However, a number of patients are either incapable of or unwilling to monitor their medical condition, and then decide upon and institute the appropriate remedial action in order to remain in a relatively stable condition.
For example, a number of children are afflicted with juvenile diabetes. Like adults who are diabetic, children stricken with juvenile diabetes must test their blood sugar several times during a day and must adjust their medication, diet and/or level of exertion in order to maintain their blood sugar at a relatively normal level since failure to maintain their blood sugar at a relatively normal level may cause the child to suffer a diabetic seizure and, over an extended period of time, may lead to blindness, amputation, strokes and even death. Notwithstanding the severe consequences of failing to maintain their blood sugar at a relatively normal level, children oftentimes become preoccupied with other activities and fail to test their blood sugar as frequently as desired. Even in instances in which a child does test his or her blood sugar on a frequent basis, the child may lack the knowledge and experience that is required to determine the remedial steps that should be taken in order to return their blood sugar to a normal level. In addition, a number of elderly patients may be either unable or unwilling to repeatedly monitor their medical condition and to make an educated decision as to whether remedial action is necessary and, if so, what type of remedial action is required in order to remain in a relatively stable condition.
In these situations in which the patient, such as a child or an elderly person, is either unable or unwilling to gather the medical data, interpret the medical data and/or take appropriate remedial actions, a physician, a nurse or other caregiver must intervene in order to remedy the situation. Unfortunately, except in instances in which the patient is hospitalized or is a resident at a nursing home, an extended care facility or the like, the patient is generally remote from the physician, nurse or other caregiver.
In order to obtain the assistance of a physician, a nurse or other caregiver, the patient may be required to visit the physician""s office on both a very frequent basis as well as in instances in which abnormal medical data is detected. Even in instances in which the patient promptly goes to the physician""s office following the detection of abnormal medical data, some time delay will occur between the detection of the abnormal data and the conference between the patient and the physician. During this time delay, the condition of the patient may worsen since the patient may otherwise fail to take proper remedial action until they have consulted with their physician. This time delay is obviously further exacerbated in instances in which the patient fails to identify an abnormal situation. In addition to the potentially harmful effects to the patient""s health occasioned by the failure to remedy the situation until after visiting the physician""s office, the patient will incur substantial costs for each office visit, thereby potentially discouraging the patient from visiting the physician as often as otherwise desirable in a misguided attempt to reduce medical costs.
In order to properly treat the patient""s condition and to identify the cause of the problem, a physician oftentimes would like to have additional medical data from earlier in the day, the prior day or even before. As such, a variety of monitors have been developed for monitoring a number of medical conditions that include memory devices for storing the medical data for some period of time such that a physician can download the medical data during the patient""s visit to the physician""s office in order to review at least the recent history of the patient. For example, blood glucose meters have been developed for monitoring the blood sugar of a patient and for storing the measured values obtained over a period of time, typically with a time and date stamp defining when the blood sugar reading was obtained. Likewise, heart monitors having memory devices have been developed and are worn by patients to monitor and store their pulse rate, their heart rhythm and the like.
In addition to a monitor, the patient oftentimes require the number of accessories. For example, in order to monitor the blood sugar of a diabetic patient, the patient not only must carry a blood glucose meter, but also must generally carry a number of lancets and a lancing device. In addition, a diabetic patient must also typically carry a number of test strips as well as a vial of calibration liquid. As such, carrying cases have been developed for storing the blood glucose meter and the testing accessories. Some patients, however, carry the various accessories loosely in their briefcase, purse, backpack or the like and, as a result may have difficulty readily locating all of the necessary accessories in order to test their blood sugar since the briefcase, purse, backpack or the like generally includes a large number of other items. In addition, the accessories must generally be quite clean in order to attain accurate readings. As such, storage of the accessories in a loose manner in a briefcase, purse, backpack or the like may undesirably soil or otherwise contaminate the accessories and therefore somewhat decrease the reliability of the resulting readings. In addition, for those tests that draw blood, such as tests of a patient""s blood sugar, the accessories, such as the lancets and test strips, that are utilized for the test may need to be stored and disposed of in a controlled fashion, such as at the patient""s home. As such, a patient may also have to carry a bag or the like for collecting those accessories that have been exposed to blood.
In order to permit patients to provide their physician with medical data without having to visit the physician""s office, systems have been developed that permit a patient to periodically log onto a computer in their home or office and to then uplink the medical data collected by the monitor to their physician for analysis. Upon analyzing the medical data, the physician can contact the patient if the medical data is abnormal or is approaching abnormal levels in order to ask the patient to either visit the physician at the physician""s office for a more thorough examination or to prescribe some remedial action such as by adjusting the patient""s medication, diet and pattern of rest and exercise such that the patient""s condition will stabilize. While these systems free the patient from having to visit the physician""s office as frequently, these systems still impose some delay between the time at which the medical data is collected and the time that the physician analyzes the medical data and suggests remedial action, if necessary. For example, in some of these systems, the monitor that is worn by the patient collects data at fairly regular intervals. The medical data may be uplinked to the physician, however, on a less frequent basis. As such, some delay is introduced between the time of collecting the data and the time of uplinking the medical data to the physician.
In order to further reduce any delays between the collection of the medical data by the patient and the provision of the medical data to a physician, systems have been developed to transmit the medical data collected by a patient to their physician without requiring the patient to log onto their computer and uplink the medical data to the physician. In this regard, systems have been developed that provide for the medical data to be transmitted from the patient to a computer or computer network that is accessible by the physician while the patient is engaged in their day-to-day activities. For example, the monitor can be configured to wirelessly transmit the medical data to a host computer for transmission to their physician on either a relatively continuous basis or on a periodic basis. In addition, the host computer can analyze the medical data and identify seemingly abnormal medical data. For example, in a system designed to permit a diabetic to transmit their blood sugar readings to their physician, the host computer can be configured to identify instances in which the blood sugar readings are either too high or too low and to provide an alert to the physician such that the physician can more quickly analyze the medical data and contact the patient with an appropriate remedy. In order to facilitate communications between a physician and the patient, some of these systems also provide a communications link from the physician to the patient such that the physician can transmit messages or actually verbally communicate with the patient in instances in which the physician wishes to prescribe appropriate remedial treatment.
While these systems are effective in uplinking medical data to a physician, a physician oftentimes would like to have additional data relating to activities of the patient since this additional data may assist in interpreting the medical data and formulating the proper treatment plan. With respect to a diabetic patient, for example, a physician is desirous not only of the blood sugar readings of the patient over a period of time, but also data relating to the time and content of the meals eaten by the patient, the time and duration of various physical activities undertaken by the patient and the time and duration of any periods of rest or sleep enjoyed by the patient. Based upon this additional data, the physician may determine if fluctuations in the blood sugar of the patient are attributable to the activities of the patient and, if so, may suggest modifications in the activities of the patient in order to ensure that the blood sugar of the patient remains within a desired range. In instances in which a patient physically visits a physician, the patient may describe their activities in order to assist the physician in analyzing the medical data. However, these descriptions are oftentimes incomplete and somewhat inaccurate as the patient may have difficulty remembering each activity to the level or detail desired by the physician.
As described by U.S. patent application Ser. No. 09/883,708 filed Jun. 19, 2001 by Louis G. Nemeth, et al., the contents of which are incorporated herein by reference in their entirety, systems have been developed for permitting medical data collected by ambulatory patients to be annotated with data defining various activities of the patients. In these systems, the medical data and the related data defining the activities of the patient may be transmitted to the physician without requiring the patient to visit the physician. While these systems advantageously provide the physician with a great wealth of information in addition to the medical data in order to assist in the interpretation of the medical data and to prescribe proper treatments for the medical condition, these systems generally require a computing device in addition to the medical monitoring device since the medical monitoring device is not generally configured to accept additional data relating to the activities of the patient. In this regard, the system may also include a portable computing device, such as a personal data assistant (PDA) or other personal information manager (PIM), a mobile telephone, a laptop computer or the like, which communicates with the medical monitoring device and which accepts input by the patient, such as input defining various activities of the patient. The portable computing device may also communicate with a computer system accessible by the physician in order to provide the physician with the medical data collected by the medical monitoring device as well as related data defining various activities of the patient. As such, a patient must not only carry the medical monitoring device and the related accessories, but also the computing device in order to provide detailed information relating to their various activities. As will be apparent, the addition of the computing device further complicates matters for the patient since the patient must carry the medical monitoring device and its related accessories as well as the computing device with them as they travel about during the day. In this regard, while carrying cases have been developed for storing a medical monitoring device and its related accessories, these carrying cases make no provision for a computing device and, as a result, the computing device must be carried separately.
In addition to medical data relating to the physiological and biological status of a patient, it would also be desirable to monitor other types of medical data including medical data that is not naturally occurring or preexisting within the patient. For example, it would be desirable to monitor and analyze medical data relating to biologically, medically or scientifically relevant drugs, proteins, hormones, molecules, chemicals, atoms, isotopes, compounds or other exogenous materials that are administered or applied to the patient. These materials may be administered or applied to the patient for a wide variety of purposes including the monitoring, diagnosing or treating of the patient, study or research including the study of normal physiology or behavior, the prevention of illness, the enhancement or embellishment of preexisting patient physiology or behavior or risk identification associated with patient physiology or behavior.
As a result of the wide variety of medical data that may be collected and analyzed, the third parties to whom the medical data is distributed may be equally varied and may desirably include pharmaceutical companies, biotechnology companies, research institutions, clinical trial organizations and the like, in addition to or instead of third parties who are responsible for the care of the patient. It would therefore be desirable to have a robust system and method for collecting and analyzing the wide variety of medical data and for selectively distributing information relating to the medical data to selected third parties for any of a variety of purposes.
Regardless of the type of medical data and the third party to whom information relating to the medical data will be distributed, it would be desirable to collect the medical data while the patient is ambulatory, or mobile. Furthermore, it would be desirable to provide an improved system for carrying a medical monitoring device and its related accessories, as well as any associated computing device in an organized and compact manner, while preventing contamination or soiling of the accessories. Moreover, it would be desirable to carry the medical monitoring device and any associated portable computing device in such a manner that the medical monitoring device and the portable computing device may communicate with one another, as well as with a remote computing device, such as the personal computer of the patient or a computer network, such as a computer network accessible by the patient""s physician or other third party.
A portable storage case for housing a medical monitoring device is therefore provided that facilitates communications with the medical monitoring device, such as the downloading of data collected by the medical monitoring device, while the portable storage case is in transport. Advantageously, the portable storage case may store not only the medical monitoring device, but also the accessories required for the tests and a portable computing device for, among other things, receiving additional data relating to the various activities of the patient. As such, the portable storage case maintains the medical monitoring device, the portable computing device and all related accessories in a compact and organized manner while preventing soiling or other contamination of the accessories. In addition, a method for communicating with a medical monitoring device stored within a portable storage case is also provided according to the present invention.
According to one aspect of the present invention, a portable storage case is provided for housing a medical monitoring device, such as a blood glucose meter or the like. The portable storage case includes a case body defining an internal compartment. The case body is capable of being opened to access the internal compartment and those items therewithin. The portable storage case also includes a holder disposed within the internal compartment of the case body for receiving the medical monitoring device. The portable storage case may also include a number of subcompartments carried by the case body and disposed within the internal compartment for storing accessories associated with the medical monitoring device. In this regard, the portable storage case may include a disposable container, such as a disposable pouch, for collecting consumables following their use. The disposable container is preferably replaceable such that a container that has been at least partially filled with used consumables may be replaced with a new, empty container.
The portable storage case advantageously includes an integral data connector disposed within the internal compartment in a predetermined positional relationship with respect to the holder. As such, communication may be established between the integral data connector and a corresponding data connector carried by the medical monitoring device such that data collected by the medical monitoring device may be accessed, such as by being downloaded, once the medical monitoring device is received by the holder. The portable storage case may include various types of integral data connectors. In one embodiment, for example, the integral data connector is an integral electrical connector for establishing electrical communication with a corresponding data communications port of a medical monitoring device.
In addition to the case body and the medical monitoring device, the portable storage case of one aspect of the present invention also includes a portable computing device carried by the case body and capable of communicating with the medical monitoring device, such as via the integral data connector. In this regard, following use by the patient, data collected by the medical monitoring device may be downloaded to the portable computing device via the integral data connector of the portable storage case that engages the corresponding data connector of the medical monitoring device. The data may be downloaded to the portable computing device in accordance with a variety of different procedures, but, in one embodiment, the portable computing device includes a processing device for automatically detecting the availability of data and then triggering the medical monitoring device to download the data to the portable computing device. The portable computing device preferably includes a data entry mechanism, such as a keypad or the like, for permitting data relating to an activity of the patient to be entered. The portable computing device may also include a memory device for storing data downloaded from a medical monitoring device. In order to transmit the data collected by the medical monitoring device to a remote computing device, such as a server or the like on a computer network accessible by a physician, a parent or other third party, the portable storage case may include a modem for transmitting the data downloaded from the medical monitoring device. In this regard, the portable computing device may include the modem or, alternatively, the modem may be separate from the portable computing device.
The portable storage case is preferably configured to store the medical monitoring device, the portable computing device and all accessories in an organized and compact fashion and in a manner that reduces the risk of soiling or other contamination of the accessories. Moreover, the portable storage case is preferably configured to permit use of the portable computing device without exposing the medical monitoring device and the related accessories, thereby reducing the visibility of the medical monitoring device and the related accessories which may make the patient or others feel uncomfortable. As such, the portable storage case may include a divider for separating the internal compartment into first and second sections. In this regard, the holder and the medical monitoring device are disposed in the first section, along with the related accessories, while the portable computing device is disposed in the second section. Thus, the portable computing device is physically and visibly separated from the medical monitoring device and the related accessories.
In use, the medical monitoring device is utilized to collect medical data from a patient, such as by analyzing a sample of blood and determining the blood sugar of the patient. Data collected by the medical monitoring device is then downloaded from the medical monitoring device stored within the portable storage case to the portable computing device carried by the portable storage case. In this regard, in embodiments in which the portable storage case includes an integral data connector in communication with the portable computing device, docking of the medical monitoring device within the storage case also establishes communication between the integral data connector and the corresponding data connector of the medical monitoring device to thereby permit data collected by the medical monitoring device to be downloaded to the portable computing device via the integral data connector. Moreover, data that has been collected by the medical monitoring device may be automatically detected by the portable computing device such that downloading of the data to the portable computing device is triggered if it is detected that data is available. Additional data may also be entered via the portable computing device to describe various activities of the patient in order to supplement the medical data collected by the medical device. Finally, the data downloaded from the medical monitoring device, as well as any additional data entered via the portable computing device, may be transmitted to a remote computing device and/or stored for later transmission or analysis.
Therefore, the portable storage case permits the medical monitoring device, related accessories and a portable computing device to be housed in a compact and inconspicuous manner while also facilitating downloading of the data collected by the medical monitoring device. In this regard, the data may be collected while the portable storage case is in transport and then transmitted to a remote computing device for analysis and, in some embodiments, to trigger alerts of various third parties, including physicians, parents and the like, if the medical data fall outside of predetermined bounds. As such, the portable storage case permits an ambulatory patient to readily carry all of the various devices and accessories required to collect the necessary medical data throughout the day while preventing the accessories from becoming soiled or otherwise contaminated. Moreover, the portable storage case and associated method permits medical data and any related data defining the activities of the patient to be transmitted while the patient remains on the move, such as to a physician, parent, caregiver or other third party, in order to reduce any delays between the time at which medical data is collected and any necessary treatment of the patient is administered.